BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALGENE 20L CARBOY (ACCESSORY FOR BENCHMARK)

    MDR report key: 640054 · Received October 3, 2005

    Report

    Report Number
    2028492-2005-00004
    Event Type
    Injury
    Date Received
    October 3, 2005
    Date of Event
    September 16, 2005
    Report Date
    September 29, 2005
    Manufacturer
    VENTANA MEDICAL SYSTEMS (VMSI)
    Product Code
    KPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A VENTANA MEDICAL SYSTEMS, INC (VMSI) TECHNICAL MARKETING REPRESENTATIVE (TMR) SLIPPED ON REAGENT FLUID (EZ PREP) THAT HAD LEAKED ONTO THE FLOOR DURING AN INSTRUMENT INSTALLATION AT A CUSTOMER SITE. THE TMR REPORTED THE FOLLOWING INJURIES: FRACTURED FINGER, SPRAINED ANKLE, STRAINED NECK. SHE WAS TREATED AND RELEASED FROM THE EMERGENCY ROOM AT THE CUSTOMER SITE. THE REAGENT WAS CONTAINED IN A 20L CARBOY THAT HAS A SPIGOT. THIS CARBOY IS SOLD BY VENTANA AS AN ACCESSORY COMPONENT FOR THE BENCHMARK SERIES SLIDE STAINING INSTRUMENTS. THE CARBOY IS USED TO DILUTE VENTANA BULK FLUIDS USED FOR IMMUNOHISTOCHEMICAL AND IN SITU HYBRIDIZATION TISSUE STAINING. THE NIGHT BEFORE THE INCIDENT THE TMR FILLED THE CARBOY AND LEFT IT ON THE BENCH TOP COUNTER. THE TMR STATED THAT THE CARBOY WAS NOT LEAKING FLUID AT THAT TIME. WHEN THE TMW RETURNED TO THE SITE THE NEXT MORNING SHE SLIPPED AND FELL DUE TO LEAKED FLUID FROM THE CARBOY. SHE NOTED THE CARBOY HAD BEEN MOVED FROM COUNTERTOP TO THE FLOOR UNDERNEATH THE COUNTER AND THE SPIGOT APPEARED TO BE PARTIALLY DISCONNECTED FROM THE CARBOY. THE CARBOY WAS RETURNED TO VMSI FOR INVESTIGATION, HOWEVER THE SPIGOT HAD BEEN REMOVED FROM THE CARBOY MAKING A ROOT CAUSE EVALUATION IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NALGENE 20L CARBOY (ACCESSORY FOR BENCHMARK) PLASTIC CARBOY KPA VENTANA MEDICAL SYSTEMS (VMSI) NALGENE: 2320-0050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R